THE ROLE OF PATIENT ADVOCATES IN MEDICAL RESEARCH Haavi Morreim Deborah Collyar Steve Peckman

An "Advocate" By Any Other Name … Managed care utilization review clerk Consumer groups fighting managed care Hospital employee addressing patient complaints Groups seeking increased research funding for identified diseases Designated assistant for 'mentally infirm' people enrolled in research trials Assistant during informed consent process Nonparticipatory monitor of informed consent process Ongoing assistant for research participants

One Example of Patient Advocacy in Research: IPAC: Independent Patient Advocacy Council AbioCor Artificial Heart Trial

Completely implantable bi-ventricular cardiac replacement Initial feasibility study: 15 patients at 6 sites, nationwide Eligibility –Death 70% likely within 30 days –Unresponsive to maximum existing therapies –Ineligible for cardiac transplantation –(additional criteria)

IPAC FUNCTIONS –CLINICAL: Assisting prospective AbioCor candidates and enrolled patients –POLICY: Corporate advisory on ethical issues associated with the trial

IPAC STRUCTURE Members: site-based (6) + chair Independence –Irrevocable trust, lump-sum Company can never touch funds, can not threaten withdrawal of funds to influence IPAC IPAC governs all expenditures Membership self-selected exc. first few; company cannot 'hire' or 'fire' –Self-governing IPAC, not company, defines "patient advocacy" IPAC chooses topics for corporate advisory

CLINICAL FUNCTION INFORMED CONSENT PROCESS –Separate sessions with prospective patient, family (P/F) –Help P/F understand information, identify questions –Help P/F to think about end-of-life, quality-of-life values –Nondirective: *Not* to recommend one decision over another –*Not* to replace PI's responsibility for informed consent POST-IMPLANT: ONGOING CONTACT –Visit frequently (2-3/week or more) –Help P/F address issues arising post-implant (e.g. media issues, end-of-life issues) –Help gather information, identify resources to address concerns